KV Pharma Cuts Price of Costly Premature Birth Prevention Drug

April 1, 2011— -- Bowing to heavy pressure from the medical community and the Food and Drug Administration, KV Pharmaceuticals slashed the cost of its pricey drug to prevent premature births, Makena, today by half.

KV cut the price of a dose of Makena, its branded version of a progesterone shot that previously sold for $20 a pop, from $1,500 per dose to $690. The company also announced an expanded financial assistance program for obtaining the drug.

But many advocates and organizations working on behalf of maternal health -- such as the March of Dimes, the American College of Obstetrics and Gynecology, the American Academy of Pediatrics and the Society for Maternal Fetal Medicine -- say this pricing Band-Aid won't cut it.

The March of Dimes, which has had a corporate relationship with KV for years, announced it would sever all ties with the pharmaceutical company over the Makena ordeal.

"The company's handling of the launch of Makena, and the initial list price, were highly unsatisfactory and unacceptable to the March of Dimes and the families we represent," the organization said in a press release.

But a recent move by the FDA could open a low-cost way to obtain the progesterone shot.

Under FDA exclusivity rules, production of the cheaper version of the drug by specialty compounding pharmacies would ordinarily have to cease. Following the public outcry over KV's pricing, however, the FDA announced Wednesday that it had no intention of enforcing its own rules, reopening the doors for women to continue to obtain an affordable version of the drug, known clinically as 17P

KV had sent cease-and-desist letters to compounding pharmacies regarding 17P in error, the FDA said Wednesday, saying it would only step in to halt production when the safety of the product was in question.

The FDA granted KV approval to produce this already-in-use drug in February, a move many maternity experts hoped would offer a more regulated and readily available version of the shot. When KV announced it would charge about hundred times what patients were paying at compounding pharmacies, a firestorm of criticism ensued, and the pharmaceutical company has backpedaled on its pricing.